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Vitamin D Deficiency clinical trials

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NCT ID: NCT01535508 Completed - Clinical trials for Vitamin D Deficiency

Open Label Clinical Trial of Vitamin D in Children With Autism

Start date: February 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Primary: to investigate tolerability of interventional high dose Vitamin D3 supplementation, titrated to reach serum levels near the high end of the reference range (30-100 ng/ml), in vitamin D deficient pediatric Autism Spectrum Disorder (ASD) patients. The study will determine if initial safety and effect estimates predict that a double blind randomized control trial (RCT) with a larger set of patients will be worthwhile in the localization of this treatment aimed at improving the symptoms of ASDs. Exploratory: to determine efficacy of high dose D3 replacement for improvement in the core symptoms of autism, including sociability, eye contact, anger outbursts, stimming behavior, and sleep, as determined by parental and clinical evaluation scales.

NCT ID: NCT01524874 Completed - Diabetes Clinical Trials

Comparative Effectiveness of Vitamin D and Repletion Strategies

CEDARS
Start date: August 2010
Phase: N/A
Study type: Interventional

The importance of vitamin D (VitD) in the prevention and treatment of human health conditions has gained increased attention in recent years. As a result, medical providers of all categories are screening clinical VitD status frequently, yet become challenged with how to best advise patients regarding repletion of VitD status, i.e. which form of VitD replacement is most effective. It has been recognized that to achieve significant effects - serum concentrations >30ng/ml (75 nmol/ml) - it is necessary, as well as safe, to recommend substantially higher doses than were previously thought sufficient. These higher doses can be easily achieved orally. This clinical trial aims to compare absorption of three available forms of this fat-soluble vitamin, due to the potential differences in absorption of different preparations. High-quality powdered, chewable and lipid-emulsified VitD are readily available as supplements, yet these have not been systematically compared. This three-arm, randomized clinical trial will compare the difference in serum 25-hydroxycholecalciferol (25-OH)D concentration between the three arms at baseline and after random administration of one of the three VitD preparations for 12-weeks at a dosage of 10,000 IU VitD per day. The investigators hypothesize that the three forms of vitD will result in an equivalent increase in serum 25OHD.

NCT ID: NCT01519986 Completed - Clinical trials for Vitamin D Deficiency

The Effect of Fat on Vitamin D Absorption

VITD_100484
Start date: September 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the absorption of dietary supplement of vitamin D3 (cholecalciferol), through the variation of 25 (OH) D levels, as the fat content of the meal associated with the administration of the supplement.

NCT ID: NCT01512537 Completed - Clinical trials for Vitamin D Deficiency

Alternative Treatments of Vitamin D Deficiency

Start date: February 2010
Phase: N/A
Study type: Interventional

The purpose of the study is to compare the efficiency of UVB and vitamin D supplementation in treatment of vitamin D deficiency.

NCT ID: NCT01508845 Completed - Clinical trials for Vitamin D Deficiency

A Pilot Study of the Effect of Dietary Fat Type and Amount on Vitamin D3 Absorption

MUFA/PUFA
Start date: January 2012
Phase: N/A
Study type: Interventional

This study will examine whether the amount and type of fat, mono-unsaturated fat (MUFA) vs. poly-unsaturated fat (PUFA), in a meal affects the absorption of vitamin D, which is taken after that meal. The study hypothesis is that vitamin D3 absorption will be greater when fat is present vs. absent in the meal. A secondary hypothesis is that vitamin D3 absorption will be greater in the presence of a meal with a high MUFA/PUFA compared with a low MUFA/PUFA ratio.

NCT ID: NCT01506557 Completed - Clinical trials for Vitamin D Deficiency

Vitamin D Supplementation of Lactating Mothers

MAVID
Start date: March 2011
Phase: Phase 4
Study type: Interventional

The investigators would like to test the hypothesis that maternal vitamin D supplementation during lactation in dose 1200IU/d (400IU from multivitamins + 800 IU cholecalciferol) is more effective than 400IU/d (400IU from multivitamins + placebo)to built appropriate maternal vitamin D status and could be beneficial for maternal and infants bone mineralization and body composition (proper proportion of muscle and fat tissues in body weight) and is safe for both. The investigators also want to confirm that vitamin D supplementation of exclusively breastfed infants in dose 400IU/d is adequate to build appropriate vitamin D status independently of mother's vitamin D supplementation up to 1200 ID/d. Additionally the investigators hypothesize that because of changes in lifestyle there will be no substantial seasonal differences in vitamin D status of pregnant women at the delivery and their newborn infants.

NCT ID: NCT01503216 Completed - Clinical trials for Vitamin D Deficiency

Safety and Bioefficacy of Vitamin D2 and Vitamin D3

Start date: January 2012
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the bioavailability of vitamin D2 and D3 as measured by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively, and by total 25(OH)D.

NCT ID: NCT01497132 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2

EVIDENS
Start date: January 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate if treatment with vitamin D increase beta cell function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes mellitus type 2.

NCT ID: NCT01490333 Completed - Clinical trials for Cardiovascular Diseases

Sunweavers: Supporting Native American Women's Vitamin D Research

Start date: July 2011
Phase: Phase 2
Study type: Interventional

Cardiovascular disease (CVD) and diabetes occur commonly among Native Americans (NA), and are leading causes of death among northern US NAs. Moreover, low vitamin D status occurs commonly in this same population. An increasing amount of evidence indicates a correlation between low vitamin D status and CVD and diabetes by contributing to a heightened pro-inflammatory environment within the endothelial lining of blood vessels leading to atherosclerotic disease, and an impaired sensitivity to insulin leading to diabetes. Our fundamental hypothesis is that low vitamin D status is a risk factor for CVD by causing a proinflammatory milieu, thereby leading to endothelial dysfunction. Additionally, the investigators hypothesize that vitamin D supplementation will reduce inflammation, thereby restoring endothelial function and ultimately reducing CVD risk.

NCT ID: NCT01488734 Completed - Metabolic Syndrome Clinical Trials

Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom

Start date: November 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of two different amounts of vitamin D2 (600 or 4000 International Units/day) provided by mushrooms added to one of the daily meals versus same doses of vitamin D3 provided as oral supplements sold in any drugstore in reaching adequate or optimal blood levels of 25(OH)D in people with Vitamin D deficiency and pre-diabetes (high blood sugar without full blown diabetes) or the metabolic syndrome. Metabolic syndrome is the name of a group of risk factors that raise the risk for heart disease and other health problems, such as diabetes and stroke as described by the US department of Health and Human Services. This study will also attempt to demonstrate and compare the effect of the intervention with above two doses of vitamin D on blood levels of tests that show inflammation.